FDA Guidance
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 — Updated 9/17/2021
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations — Updated 8/3/2020
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product — Updated 5/6/20
- Draft Guidance for Industry on Considerations in Demonstrating Interchangeability with a Reference Product — Updated 5/6/2020
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product — Updated 4/24/20
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product — Updated 2/27/2020
- Nonproprietary Naming of Biological Products — Updated 11/18/2019
- Labeling for Biosimilar Products — Updated 11/18/2019
- Draft Guidance for Industry on Labeling for Biosimilar Products — Updated 11/18/2019
- Draft Guidance for Industry on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA [Biosimilar User Fee Act] Products — Updated 10/30/2018
- Designation of Official Names and Proper Names for Certain Biological Products — Updated 8/28/2015
- Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 — Updated 4/30/2015